RELISTOR tablets: >25% of the time, adult patients with OIC and chronic non-cancer pain (CNCP) experienced an SBM within 4 hours of dosing1

*Defined as bowel movement without the use of any laxative in previous 24 hours.

†During the 4-week double-blind period.

‡Three RELISTOR 150-mg tablets (450 mg total) once daily in the morning with water on an empty stomach at least 30 minutes before the first meal of the day.

In a 4-week randomized, double-blind, placebo-controlled study, the efficacy of RELISTOR tablets was evaluated in 401 adult patients (200 RELISTOR tablets, 201 placebo) with CNCP for which they were taking opioids2

All patients had OIC, defined as <3 SBMs per week, and at least one additional symptom of constipation2

IMPORTANT SAFETY INFORMATION

RELISTOR injection: a third of adult patients with OIC and CNCP experienced an SBM§ within 4 hours of their first dose2,3

§Defined as bowel movement without the use of any laxative in previous 24 hours.

In a 4-week double-blind, randomized, placebo-controlled study, the efficacy of RELISTOR injection for adult OIC was evaluated in 312 patients (150 RELISTOR injection, 162 placebo) with CNCP for which they were taking opiates2

All patients had OIC, defined as <3 SBMs per week and at least one additional symptom of constipation2

All patients had OIC, defined as either <3 bowel movements in the preceding week or no bowel movement within 2 days2

Patients maintained their regular laxative regimen for at least 3 days prior to study entry and throughout the study

Rescue laxatives were prohibited from 4 hours before to 4 hours after receiving an injection of study medication

IMPORTANT SAFETY INFORMATION

The most common adverse reactions (≥5%) were abdominal pain, flatulence, nausea, dizziness, and diarrhea2

¶Rescue-free laxation within 4 hours of the first dose.

In a 2-week double-blind, randomized, placebo-controlled trial followed by a subsequent open-label extension study of up to 4 months, the efficacy of RELISTOR injection was evaluated in 133 patients (62 RELISTOR injection, 71 placebo) with advanced illness and OIC2

All patients had OIC, defined as either <3 bowel movements in the preceding week or no bowel movement within 2 days2

Patients maintained their regular laxative regimen for at least 3 days prior to study entry and throughout the study

Rescue laxatives were prohibited from 4 hours before to 4 hours after receiving an injection of study medication

IMPORTANT SAFETY INFORMATION

The most common adverse reactions (≥5%) were abdominal pain, flatulence, nausea, dizziness, and diarrhea2

Indications

RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Limitations of Use: Use beyond four months has not been studied in the advanced illness population.

RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.

A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

RELISTOR is a registered trademark of Salix Pharmaceuticals or its affiliates.

8540 Colonnade Center Drive, Raleigh, NC 27615 USA

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INDICATIONS

RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
Limitations of Use: Use beyond four months has not been studied in the advanced illness population.

RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.

A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.

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